COPD Clinical Research Network & Clinical Research Skills Core Development

描述(由申请人提供)： 慢性阻塞性肺疾病(COPD)是一种致命和病态的疾病，每年有60多万人住院治疗，1340万人次就诊。每年用于慢性阻塞性肺病的直接医疗费用超过150亿美元，工作效率下降造成的损失约为99亿美元。在美国和全世界，与COPD相关的患病率、发病率和死亡率都在以惊人的速度增长。人们越来越意识到，COPD的恶化不仅与患者生活质量的恶化有关，而且还直接导致患者住院、增加死亡率和增加护理成本。该项目的目的是参与国家、心肺和血液研究所(NHLBI)COPD临床研究网络(CRN)，以多学科的方式调查中重度COPD患者的疾病管理方法。我们还建议开发一个临床研究技能开发核心，以帮助天普的新临床研究人员发展开发临床研究计划所需的临床技能。这一计划还将被用来进一步磨练现有调查人员的技能，以发展到更高级的调查状态。COPD临床研究网络的具体目标将是：1)通过测试中重度COPD管理的特定方法来加强治疗决策的知识库；2)改进与COPD相关的合并症的管理；3)开发预测个别患者对治疗的反应的方法；以及4)评估和关联各种结果衡量标准。我们两项技术提案的具体目标是以符合COPD临床研究网络总体目标的方式解决COPD的两个重要问题。我们的目的是：1)确定夜间给氧与安慰剂对夜间氧减饱和的中重度COPD患者的睡眠质量、功能表现、右心功能、生活质量和COPD加重频率的影响；2)与高加索人比较，确定少数民族患者(非裔美国人)需要住院治疗的COPD加重的诱因、解决模式、疾病管理和基因组学。

DESCRIPTION (provided by applicant): Chronic obstructive pulmonary disease (COPD) is a deadly and morbid disorder that accounts annually for more than 600,000 hospitalizations and 13.4 million physician office visits. More than $15 billion are expended per year in direct medical costs for COPD, and approximately $9.9 billion are lost in reduced work productivity. The prevalence, morbidity, and mortality associated with COPD is increasing at an alarming rate, both in the United States and worldwide. There is a growing awareness that exacerbations of COPD are not only associated with a worsening of the patient's quality of life, but are directly responsible for patient hospitalization, increasing mortality, and increasing costs of care. The purpose of this project is to participate in the National, Heart, Lung, and Blood Institute (NHLBI) COPD Clinical Research Network (CRN) to investigate in a multidisciplinary fashion, disease management approaches in patients with moderate to severe COPD. We also propose to develop a Clinical Research Skills Development Core to assist new clinical investigators at Temple in developing clinical skills needed to develop clinical investigative programs. This program will also be used to further hone the skills of current investigators to progress to a more senior investigative status. Specific objectives of the COPD Clinical Research Network will be to: 1) strengthen the knowledge base for therapeutic decision-making by testing particular approaches in the management of moderate to severe COPD; 2) improve the management of co-morbid conditions associated with COPD; 3) develop methods for predicting individual patient responsiveness to treatments, and; 4) evaluate and correlate various outcome measures. The specific objectives of our 2 technical proposals are to address two important issues in COPD in a manner that satisfies the overall objectives of the COPD Clinical Research Network. We intend to: 1) determine the effect of chronic, nocturnal oxygen administration vs placebo in moderate to severe COPD patients whom exhibit nocturnal oxygen desaturation on sleep quality, functional performance, right heart function, quality of life, and COPD exacerbation frequency, and: 2) to determine the inciting factors, pattern of resolution, management of disease, and the genomics of COPD exacerbations requiring hospitalization in minority patients (African American) compared to Caucasians.